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A Study to Evaluate the Effects of D-1553 on PK of Midazolam, Caffeine, Rosuvastatin, Furosemide, Digoxin, and Itraconazole or Omeprazole on PK of D-1553

Sponsor
InventisBio Co., Ltd (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT06105255
Collaborator
(none)
44
Enrollment
1
Location
3
Arms
14.3
Anticipated Duration (Months)
3.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a phase I study to evaluate drug-drug interactions (DDIs) of D-1553 as a perpetrator combined with midazolam (CYP3A4 substrate), caffeine (CYP1A2 substrate), rosuvastatin (OATP1B1/OATP1B3 substrate), furosemide (OAT1/OATP1B3 substrate), and digoxin (P-gp substrate) and to evaluate DDIs of D-1553 as a victim combined with itraconazole (inhibitor of CYP3A4 and P-gp) and omeprazole (proton-pump inhibitor) in healthy male subjects.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
44 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
A Phase I Study to Evaluate the Effects of Multiple-dose D-1553 on Pharmacokinetics of Single-dose Midazolam, Caffeine, Rosuvastatin, Furosemide and Digoxin, and to Evaluate the Effects of Multiple-dose Itraconazole and Omeprazole on Pharmacokinetics of Single-dose D-1553 in Healthy Male Subjects
Actual Study Start Date :
May 24, 2023
Anticipated Primary Completion Date :
Mar 31, 2024
Anticipated Study Completion Date :
Jul 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Multipledose D-1553 on PK of single dose midazolam, caffeine, rosuvastatin, furosemide, digoxin

To evaluate the effects of multiple-dose D-1553 tablets on pharmacokinetics (PK) of single-dose midazolam, caffeine, rosuvastatin, furosemide, and digoxin in healthy male subjects.

Drug: D-1553
D-1553 is a novel, targeted KRASG12C inhibitor.
Other Names:
  • other

    		•
    Experimental: Evaluate the effects of multiple-dose itraconazole on PK of single-dose D-1553

    To evaluate the effects of multiple-dose itraconazole on PK of single-dose D-1553 tablets in healthy male subjects.

    Drug: D-1553
    D-1553 is a novel, targeted KRASG12C inhibitor.
    Other Names:
  • other

    		•
    Experimental: Evaluate the effects of multiple-dose omeprazole on PK of single-dose D-1553

    To evaluate the effects of multiple-dose omeprazole on PK of single-dose D-1553 tablets in healthy male subjects.

    Drug: D-1553
    D-1553 is a novel, targeted KRASG12C inhibitor.
    Other Names:
  • other

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Primary PK parameters of midazolam, caffeine, rosuvastatin, furosemide, and digoxin: maximum concentration (Cmax). [Before and after co-administration of D-1553, approximately day1 and day10]

      Primary PK parameters of midazolam, caffeine, rosuvastatin, furosemide, and digoxin before and after co-administration of D-1553 tablets: maximum concentration (Cmax).

    2. Primary PK parameters of midazolam, caffeine, rosuvastatin, furosemide, and digoxin: area under the concentration-time curve from the time of dosing to time t (AUC0-t). [Before and after co-administration of D-1553, approximately day1 and day10]

      Primary PK parameters of midazolam, caffeine, rosuvastatin, furosemide, and digoxin before and after co-administration of D-1553 tablets: area under the concentration-time curve from the time of dosing to time t (AUC0-t).

    3. Primary PK parameters of midazolam, caffeine, rosuvastatin, furosemide, and digoxin: area under the concentration-time curve from time 0 to infinity (AUC0-∞). [Before and after co-administration of D-1553, approximately day1 and day10]

      Primary PK parameters of midazolam, caffeine, rosuvastatin, furosemide, and digoxin before and after co-administration of D-1553 tablets: area under the concentration-time curve from time 0 to infinity (AUC0-∞).

    4. Primary PK parameters of D-1553: maximum concentration (Cmax). [Before and after co-administration of itraconazole, approximately day1 and day9]

      Primary PK parameters of D-1553 before and after co-administration of itraconazole: maximum concentration (Cmax).

    5. Primary PK parameters of D-1553: area under the concentration-time curve from the time of dosing to time t (AUC0-t). [Before and after co-administration of itraconazole, approximately day1 and day9]

      Primary PK parameters of D-1553 before and after co-administration of itraconazole: area under the concentration-time curve from the time of dosing to time t (AUC0-t).

    6. Primary PK parameters of D-1553: area under the concentration-time curve from time 0 to infinity (AUC0-∞). [Before and after co-administration of itraconazole, approximately day1 and day9]

      Primary PK parameters of D-1553 before and after co-administration of itraconazole: area under the concentration-time curve from time 0 to infinity (AUC0-∞).

    7. Primary PK parameters of D-1553: maximum concentration (Cmax). [Before and after co-administration of omeprazole, approximately day1 and day8]

      Primary PK parameters of D-1553 before and after co-administration of omeprazole: maximum concentration (Cmax).

    8. Primary PK parameters of D-1553: area under the concentration-time curve from the time of dosing to time t (AUC0-t). [Before and after co-administration of omeprazole, approximately day1 and day8]

      Primary PK parameters of D-1553 before and after co-administration of omeprazole: area under the concentration-time curve from the time of dosing to time t (AUC0-t).

    9. Primary PK parameters of D-1553: area under the concentration-time curve from time 0 to infinity (AUC0-∞). [Before and after co-administration of omeprazole, approximately day1 and day8]

      Primary PK parameters of D-1553 before and after co-administration of omeprazole: area under the concentration-time curve from time 0 to infinity (AUC0-∞).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Subjects who volunteer to participate in this clinical trial, understand the study procedures and sign the Informed Consent Form (ICF) in writing.

    • Male, aged 18-45 years (both inclusive) at the time of signing the ICF.

    • Non-smokers or subjects who smoked no more than 5 cigarettes or 1 pipe per day within 3 months prior to screening.

    Exclusion Criteria:

    • Subjects with any clinically significant acute diseases as judged by the investigators within one month prior to screening.

    • Subjects who are positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or Treponema pallidum antibody.

    • Subjects with a history of blood or needle phobia.

    • Subjects with a history of hypersensitivity to the investigational drug and/or any preparation ingredients.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shanghai Xuhui District Central Hospital Shanghai Shanghai China 200031

    Sponsors and Collaborators

    • InventisBio Co., Ltd

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    InventisBio Co., Ltd
    ClinicalTrials.gov Identifier:
    NCT06105255
    Other Study ID Numbers:
    • D1553-107
    First Posted:
    Oct 27, 2023
    Last Update Posted:
    Oct 27, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Oct 27, 2023